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Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy

Dexamethasone as an Adjuvant to Ropivacaine for Femoral Nerve Blocks in Children Undergoing Knee Arthroscopy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01971645
Enrollment
77
Registered
2013-10-29
Start date
2014-07-31
Completion date
2016-09-30
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injury

Keywords

Dexamethasone, Ropivacaine, Knee arthroscopy, Femoral nerve blocks, Peripheral nerve blocks, Adjuvant, Pediatrics

Brief summary

If preservative-free dexamethasone 0.1 mg/kg (max dose 4 mg) is added to ropivacaine 0.5% 2 mg/kg (max dose 100 mg), then post-PACU opioid consumption will be reduced by 33%.

Detailed description

Following informed consent, patients will be randomized to one (1) of three (3) arms. Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml). Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml). Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg). The randomization will be blinded to the patient, surgery team, anesthesia team, recovery nurses, and clinical research nurses. The remainder of the anesthetic care will remain the same per our usual routine for these cases. On arrival to the operating room: 1. Standard American Society of Anesthesiologists (ASA) monitors will be placed on the patient (ECG, pulse oximetry, non-invasive BP, thermistor). 2. A peripheral intravenous catheter will be placed while patient is inhaling 50% nitrous oxide. 3. Intravenous induction will be accomplished with midazolam 2 mg, propofol 2-3 mg/kg. 4. Once induction is complete, a laryngeal mask airway will be placed. 5. Maintenance of anesthesia will be provided with inhaled sevoflurane titration. 6. The femoral nerve block will be performed by one of the anesthesiologist co-investigators. 7. After completion of a pre-block time-out, the patient's groin on side of surgery will be prepped with chlorhexidine. 8. Using aseptic technique, a needle will be advanced under ultrasound guidance to the femoral nerve. 9. In addition to ultrasound, a nerve stimulator may be used at the anesthesiologist's discretion to help identify the femoral nerve. 10. After identification of the femoral nerve, the perineural study drug will be injected around the femoral nerve. 11. Using aseptic technique the intramuscular study drug will be injected into the gluteus muscle. 12. For intraoperative increases in heart rate or systolic blood pressure \>20 % above levels immediately prior to incision, fentanyl will be given in 1 µg/kg increments every 5 minutes until below this threshold. (No acetaminophen, ketorolac, or IV dexamethasone will be given) 13. Once the patient arrives to PACU, dilaudid 5 µg/kg (max. dose 0.3 mg) every ten minutes may be given until patient VAS score is less than or equal to 4. 14. In the surgery unit, patients may receive one dose of hydrocodone-acetaminophen (7.5 mg/325 mg/15 ml) liquid suspension 0.1 mg/kg hydrocodone PO (max. dose 10mg hydrocodone) and then may receive dilaudid 5 µg/kg IV if pain persists above a VAS of 4 (max. dose 0.3 mg). 15. Patients will be discharged from the surgery unit with a prescription for hydrocodone-acetaminophen (7.5 mg/325 mg/15 ml) liquid suspension. The prescription will be for 0.1 mg/kg hydrocodone PO (max. dose 10 mg hydrocodone) every 4 hours as needed for all patients. 16. Patients will be sent home with a pain diary to record consumption of pain medication, when 1st dose of pain medications was taken, when sensory and motor blocks resolved and degree of motor block 24 and 48 hours according to the Bromage scale (Table 1). All adverse effects including nausea, vomiting, pruritus, excessive sedation will be asked to be recorded in the diary. 17. A clinical research nurse will collect information on opioid consumption on day of surgery (DOS) and intensity of motor block in PACU according to the Bromage scale. 18. On post-operative day 1 and 2 a clinical research nurse will call to collect information from the diary for analysis. If sensory or motor blockade persists on day 2, then the patient will be called on day 3. If neurologic symptoms persist after 72 hours, the patient will be asked to come to pre-operative clinic for a neurologic examination by an anesthesiologist. If neurological deficits are present on exam, the patient will be referred to a neurologist. Neurology will then determine if further testing is required. In addition, all patients will be contacted by telephone at 2 weeks after study initiation. If any new neurologic deficits are reported at this time, patients will be brought into the preoperative clinic and undergo the same evaluations.

Interventions

DRUGDexamethasone

Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.

DRUGRopivacaine

Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

* Children older than 10, and younger than 19 years of age undergoing unilateral arthroscopic surgery of the knee * American Society of Anesthesiologists (ASA) Status I or II * Patient's parent/guardian willing and able to give consent * Patient willing to give assent

Exclusion criteria

* Arthroscopic anterior cruciate ligament repair * Systemic steroid use within the last 3 months * Diabetes mellitus * Females testing positive for pregnancy * BMI \> 98th percentile * Positive pregnancy test * Coagulopathy * Renal or hepatic disease * Pre-existing motor or sensory deficits in the lower extremities * Predisposition for falls based on pre-existing sensory or motor deficits of the legs or inability to perform crutch training. * Non-English speaking * Systemic fungal infection * Immunosuppressed patients

Design outcomes

Primary

MeasureTime frameDescription
Intra-operative and Post-operative Opioid ConsumptionIntra-operative and up to 48 hours post-discharge, an average of 48 hoursNumber of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.

Secondary

MeasureTime frameDescription
Post-operative Pain ScoresImmediately post-operatively and up to 48 hours post-discharge, an average of 48 hoursVisual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.

Countries

United States

Participant flow

Participants by arm

ArmCount
Perineural Dexamethasone Group
Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml). Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly. Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
25
Ropivacaine Group
Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml). Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
27
Intramuscular Dexamethasone Group
Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg). Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly. Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
25
Total77

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event100
Overall StudyLost to Follow-up101
Overall StudyProtocol Violation001

Baseline characteristics

CharacteristicRopivacaine GroupIntramuscular Dexamethasone GroupPerineural Dexamethasone GroupTotal
Age, Categorical
<=18 years
26 Participants24 Participants24 Participants74 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
1 Participants1 Participants1 Participants3 Participants
Age, Continuous14.6 years
STANDARD_DEVIATION 2
14.7 years
STANDARD_DEVIATION 2
15.1 years
STANDARD_DEVIATION 2
14.8 years
STANDARD_DEVIATION 2
Region of Enrollment
United States
27 Participants25 Participants25 Participants77 Participants
Sex: Female, Male
Female
11 Participants16 Participants14 Participants41 Participants
Sex: Female, Male
Male
16 Participants9 Participants11 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
1 / 250 / 270 / 25
serious
Total, serious adverse events
0 / 250 / 270 / 25

Outcome results

Primary

Intra-operative and Post-operative Opioid Consumption

Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.

Time frame: Intra-operative and up to 48 hours post-discharge, an average of 48 hours

ArmMeasureValue (MEDIAN)
Group DIntra-operative and Post-operative Opioid Consumption2 doses
Group RIntra-operative and Post-operative Opioid Consumption2 doses
Group MIntra-operative and Post-operative Opioid Consumption3 doses
Secondary

Post-operative Pain Scores

Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.

Time frame: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours

ArmMeasureValue (MEDIAN)
Group DPost-operative Pain Scores2 units on a scale
Group RPost-operative Pain Scores2 units on a scale
Group MPost-operative Pain Scores1 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026